drugset / Trial / NCT03965195
Recombinant Influenza Vaccination in U.S. Nursing Homes
Phase 4
Unknown
1989 enrolled
Insight Therapeutics, LLC
Brown University · collabCase Western Reserve University · collabSanofi Pasteur, a Sanofi Company · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
Based on recent evidence on the mutation of the A/H3N2 strain in egg-grown vaccine, the investigators will study the quadrivalent recombinant influenza vaccine (RIV4, Flublok) compared to the standard dose quadrivalent vaccine (IV4) in a cohort of long-stay NH residents with a primary endpoint of all-cause hospitalization.
Timeline
- Start
- 2019-07-20
- Primary completion
- 2023-08
- Completion
- 2023-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Flublok | Vaccine | — | — |
| Comparator | Standard Dose Quadrivalent Influenza Vaccine | Vaccine | — | — |